MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367365

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows: common device name: intravascular administration set.Medical device type: fpa.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set there was back flow of blood from device to patient.The following information was provided by the initial reporter.The customer stated: there was "flashback and no blood obtained.".

Manufacturer Narrative

The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 22-feb-2023.H.6.Investigation summary: bd received 26 samples from the customer in support of this complaint.The 26 customer samples, along with 10 retention samples form the bd inventory, were subjected to functional testing to assess functionality of the device.All samples passed testing exhibiting obtainable flash during use.Therefore, this complaint cannot be confirmed based on customer and retain sample testing results.Bd is unable to confirm the customer¿s reported failure mode of flash based on customer sample testing analysis.Based on a review of batch records, no root cause from manufacturing was identified as a contributor.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set there was back flow of blood from device to patient.The following information was provided by the initial reporter.The customer stated: there was "flashback and no blood obtained.".

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16241989
• MDR Text Key: 308841497
• Report Number: 1024879-2023-00035
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673655
• UDI-Public: 50382903673655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367365
• Device Catalogue Number: 367365
• Device Lot Number: 2293202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1